MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-04-24 for ARCHITECT I2000SR ANALYZER 03M74-97 manufactured by Abbott Manufacturing Inc.
[73572437]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[73572438]
The customer reports that the blood samples from two known (b)(6) patients are generating negative results with the architect syphilis tp assay on an architect i2000sr analyzer. The following information was provided: (b)(6): (b)(6) 2017 = 0. 46 s/co (negative); retest at 0. 44 s/co; retest on (b)(6) 2017 with a similar negative result. Patient history was used to request additional (b)(6) testing immediately rather than just the routine architect syphilis test. (b)(6) were all (b)(6). The sample repeated on both architects as 0. 45 s/co (negative). A new sample was taken seven day later and generated a (b)(6) result. (b)(6): (b)(6) 2017= 0. 55 s/co (negative); sample not retested. This patient had tested (b)(6) with the architect system on a previous date (not provided). Since both patients were known (b)(6), extended testing was performed on both samples by two alternative methods and (b)(6) results were generated. Controls have remained within range. The customer later retested (b)(6), which generated the expected (b)(6) result on a second architect isystem in their lab. There is no impact to patient management reported. It was later discovered that the customer have used an incorrect bulk solution as the ph levels in the buffer tank indicated contamination. After thorough flushing of the analyzer both samples were retested and both generated negative results of 0. 4 s/co.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2017-00128 |
| MDR Report Key | 6515296 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-04-24 |
| Date of Report | 2017-08-22 |
| Date of Event | 2017-03-29 |
| Date Mfgr Received | 2017-08-22 |
| Date Added to Maude | 2017-04-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT I2000SR ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | GMT |
| Date Received | 2017-04-24 |
| Catalog Number | 03M74-97 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Brand Name | ARCHITECT I2000SR ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER, |
| Product Code | JJE |
| Date Received | 2017-04-24 |
| Catalog Number | 03M74-97 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-24 |